Wednesday April 8, 2020 0 comments
BOULDER -- Biodesix, Inc. announced it began SARS-CoV-2 Droplet Digital PCR (ddPCR) testing for the virus that causes COVID-19 and will immediately submit for Emergency Use Authorization from the Food and Drug Administration.
Initially, Biodesix is receiving samples from local health systems, hospitals, and clinics in the state of Colorado. The Biodesix laboratory currently has the capacity to process 1,000 COVID-19 tests per day providing results in as little as 48 hours from the sample arriving at the laboratory.
The sample for testing is collected by the patient’s healthcare provider and sent to the Biodesix CAP/CLIA/NYS CLEP approved Laboratory in Boulder for processing.
Biodesix announced a partnership on March 20 with Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) to bring a COVID-19 Droplet Digital PCR (ddPCR) test through the FDA to support the escalating need for testing in the U.S.
The launch follows the publication of two studies which reported that ddPCR testing showed superior sensitivity and precision for clinical detection of SARS-CoV-2, when compared to existing test methods that are performed using qPCR.
The findings suggest ddPCR testing can reduce false negative results of COVID-19 without any increase to false positive results and could be a powerful complement to the current standard of testing.
“Some of the most significant challenges that hospitals are dealing with are centered on testing and caring for patients suspected to have COVID-19,” said Scott Hutton, Biodesix CEO.
“Hospitals are finding severe shortages of testing supplies and extended waits for test results. The Biodesix mission is always to be patient-centric and we felt compelled to use our technology and expertise in response to the devastating virus that causes COVID-19.
“It is our belief that introducing the most sensitive test possible will aid in stopping the spread of the virus as it will reduce the number of false negative test results.”